- New Company will be a Well-Funded Pure
Play Specialty Ophthalmic Company
- BromSite™ NDA Submission to FDA to be
Promptly Filed this Week
- Alameda (InSite) and Vancouver (QLT)
Operations to Continue to Progress Phase 3 Retinoid Program
- QLT’s Canadian-Domiciled Structure
Creates Favorable Tax Environment and Provides Significant
Strategic Flexibility for Partnering/M&A
- Enables Rapid Development of Broadly
Diversified Late-Stage Product Pipeline
- Conference Call Today at 4:30 pm
Eastern Time to Discuss Transaction
InSite Vision Inc. (OTCBB: INSV) today announced that it has
reached a definitive agreement with QLT Inc. (NASDAQ: QLTI) (TSX:
QLT) under which QLT will acquire InSite in an all-stock
transaction that will create an ophthalmic specialty pharmaceutical
company with a diversified portfolio of products, full R&D
capabilities and innovative platform technologies. The transaction
is expected to drive shareholder value by accelerating both
companies’ development pipelines, increasing product diversity and
improving balance sheet strength.
The newly formed company will be incorporated in Canada and led
by a combined InSite Vision and QLT leadership team. With
operations in Alameda, California and Vancouver, British Columbia,
and headquarters in Vancouver, the new company will retain the name
of QLT, and will continue to trade on NASDAQ under the ticker
“QLTI” and on the Toronto Stock Exchange (TSX) under the ticker
“QLT”.
InSite Vision plans to promptly file a New Drug Application
(NDA) later this week with the U.S. Food and Drug Administration
(FDA) for marketing approval of its drug candidate BromSite™ to
reduce post-operative inflammation and prevent pain following
cataract surgery, and continued progression of a Phase 3 clinical
trial of QLT091001, QLT’s Orphan Drug and FDA Fast Track designated
retinoid product candidate for the treatment of inherited retinal
diseases in the first half of 2016. The merged companies expect to
file a second NDA for InSite Vision’s DexaSite™ for the treatment
of blepharitis in 2016.
The combined company expects to have approximately $70 million
in cash after the closing of the transaction and completion of
other investments and dividends announced today by QLT, all of
which dividends will be effected after the completion of the merger
and include distributions to prior InSite shareholders as new QLT
shareholders.
“The new company created by this merger will be a well-funded
pure play ophthalmic specialty company with a robust pipeline of
late-stage drug candidates, a strong cash balance with access to a
broader investor base and the opportunity for increased shareholder
value,” said Timothy Ruane, Chief Executive Officer of InSite
Vision. “The combination of InSite Vision with QLT will create a
unique new company with multiple potential value creation events in
the near- and medium-term, the potential to file multiple NDAs over
the next several years, execute on the development of a potential
successful ophthalmic retinoid product and advance a diversified
pipeline of promising product candidates for unmet eye care
needs.”
“The merger with InSite Vision is an excellent opportunity for
QLT shareholders to benefit from the combined strengths and assets
of both companies,” said Jason Aryeh, Chairman of QLT. “The InSite
Vision team has repeatedly demonstrated its ability to efficiently
execute on ophthalmic drug development, and I am excited to see our
retinoid product have the opportunity to progress in a similar
manner under our combined leadership. With a strong balance sheet
and diversified late-stage pipeline, I am excited about the future
of the company and its potential for additional value
creation.”
Combined New Company Pipeline
Product
Category & Indication Clinical
Stage Partner Status Patent
Life/Exclusivity AzaSite® (1%) Antibiotic; Bacterial
conjunctivitis
Approved: US/Canada
Pre-MAA: EU/MEA
Phase 1/2
Akorn: US & Canada
Nicox: EU/MEA
Senju: Japan
Retain ROW rights
Issued; 2019
10-years post-approval
Issued; 2020
BromSite™ NSAID; Post-cataract surgery NDA filing
this week
Pre-MAA: EU/MEA
Retain USA
Nicox: EU/MEA
Retain ROW rights
Issued; 2029 DexaSite™ Steroid; Blepharitis
2016 NDA planned Retain global rights Pending;
2029-2034 QLT091001 Retinoid; LCA/RP (Orphan Drug);
Potentially IDA
Phase 3 ready: EU/US
Planned MAA filing for conditional
approval in EU
Retain global rights Issued; 2025
Pending; 2029-2034
DexaSite™ Steroid; Post-cataract surgery Phase 3
ready Retain global rights Pending; 2029-2034 AzaSite
Plus™ Antibiotic/steroid combination; Bacteria-related
blepharitis Phase 3 ready Retain global rights
Issued 2019
Pending; 2031
ISV-101 NSAID; Dry eye disease due to inflammation
Phase 1/2 ready Retain global rights Issued; 2029
AzaSite Xtra™ (2%) Antibiotic; Neonatal infection prevention
(Orphan Drug) & bacterial conjunctivitis IND ready
Akorn: US Canada option
Nicox: EU/MEA
Retain ROW
Issued; 2027-2033 BromDex™ (DuraSite® 2) New
NSAID/steroid combination; post-cataract surgery IND
planning Retain global rights Issued; 2029 ISV-104
(DuraSite® 2)
Immunosuppressant; Dry eye disease Pre-IND
Retain global rights Issued; 2029 DuraSite® 2 Platform
Platform formulation technology; front of eye & retinal
indications Pre-IND Retain global rights
Issued; 2029
Terms of Proposed Transaction
Under the terms of the agreement, a wholly owned subsidiary of
QLT will be merged with and into InSite Vision. Shareholders of
InSite Vision will receive 0.048 QLT shares for each InSite Vision
share. For InSite Vision shareholders, the transaction represents a
27% premium based on the closing stock prices of InSite Vision and
QLT as of June 5, 2015, the last trading day prior to the
announcement of the merger. Upon completion of the merger, QLT
shareholders will own approximately 89% and former InSite Vision
shareholders will own approximately 11% of the combined company. In
addition, the merged company’s board will include two seats to be
filled by the CEO of the merged company and one director nominated
by InSite.
Approvals and Further Details
The transaction, which has been unanimously approved by the
Boards of both companies, is subject to the approval of InSite
Vision shareholders, a condition that the FDA has not refused to
accept the BromSite™ NDA for review within 60 days after InSite
Vision’s filing of the NDA, a condition that the FDA has not
indicated that it will require InSite Vision to conduct additional
clinical studies prior to approval of BromSite™ within 74 days
after InSite Vision’s filing of the NDA, and other customary
closing conditions. QLT will not require a shareholder vote to
conclude the transaction; InSite Vision will file a proxy statement
with full disclosure of the transaction and will schedule a
shareholder vote to approve the transaction. QLT will provide
InSite Vision with a line of credit until the transaction closes.
The transaction is expected to close in the third quarter of 2015
and to be taxable to InSite Vision shareholders. Shares of the new
company will trade on NASDAQ under the ticker “QLTI” and on the TSX
under the ticker “QLT”.
Advisors
Guggenheim Securities, LLC served as financial advisor to InSite
Vision, Roth Capital Partners provided an independent fairness
opinion and Jones Day served as legal advisor.
Conference Call
InSite Vision will conduct a conference call to discuss this
news release today at 4:30 pm ET. The presentation slides will be
available on the “Investors” section of InSite Vision’s website
under the “Corporate Presentations” tab. A question and answer
session will follow the presentation. Investors and other
interested parties may access the conference call by dialing
888-713-4215 for domestic callers using the passcode 10655989 and
+1 617-213-4867 for international callers using the passcode
10655989. Please dial in at least 10 minutes prior to the scheduled
start time. A telephone replay will be available following the
conclusion of the call by dialing 888-286-8010 for domestic callers
and +1 617-801-6888 for international callers using the passcode
44851286.
About DuraSite® 2 Platform
InSite’s DuraSite® 2 platform is a proprietary, advanced
delivery system designed to extend the residence time of a
topically administered therapeutic in ocular tissues located in the
front or the back of the eye. DuraSite 2 utilizes polymer-based
formulation technology to sustain and enhance ocular delivery in
the form of a gel forming suspension that can be customized to
deliver a wide variety of potential drug candidates. InSite’s
original DuraSite® platform technology, which is currently
leveraged in two commercial products for the treatment of bacterial
eye infections, AzaSite® and Besivance®, has a proven ability
to reduce frequency of treatment and improve efficacy in topical
ophthalmic therapy. DuraSite 2 represents the next generation of
topical ocular therapy, with improved drug concentration and
retention, reduced dosing frequency and the promise of delivering
medication to the front or back of the eye via topical
administration. The DuraSite 2 technology is patent protected for
use in ophthalmic drug development and disease through 2029.
About QLT Retinoid Program
QLT’s synthetic retinoid program is a replacement for
11-cis-retinal and is being developed for the treatment of retinal
diseases caused by gene mutations that interfere with the
availability of 11-cis-retinal. It has Orphan Drug Designation by
both the FDA and EMA for a significant unmet medical need. QLT has
conducted safety and proof of concept clinical studies to evaluate
its oral synthetic retinoid in patients with Leber Congenital
Amaurosis (LCA) or Retinitis Pigmentosa (RP). This innovative
ophthalmology program is ready for Phase 3 development. With its
orphan drug designation in both the United States and Europe, the
synthetic retinoid program augments InSite Vision’s broad
ophthalmology programs.
About InSite Vision
InSite Vision is advancing new specialty ophthalmic products for
the treatment of diseases affecting the front and back of the eye.
The company has two commercial products based on its innovative
DuraSite® platform approved for the treatment of bacterial eye
infections, AzaSite® (azithromycin ophthalmic solution) 1%,
marketed in the U.S. by Akorn, Inc., and Besivance® (besifloxacin
ophthalmic suspension) 0.6%, marketed by Bausch + Lomb, a wholly
owned subsidiary of Valeant Pharmaceuticals International. InSite
has a proprietary portfolio of clinical-stage product candidates,
and is currently preparing two New Drug Applications for commercial
approval by the U.S. Food and Drug Administration: BromSite™ for
the treatment of inflammation and prevention of pain associated
with cataract surgery, and DexaSite™ for the treatment of
blepharitis, and for treatment of inflammation associated with
cataract surgery. InSite’s AzaSite Plus™ is advancing through Phase
3 clinical studies for the treatment of blepharitis, and ISV-101 is
ready for Phase 1/2 clinical development for the treatment of
severe dry-eye disease due to inflammation. For further information
on InSite Vision, please visit www.insitevision.com.
Cautionary Statements Related to Forward-Looking
Statements
Statements in this document that are not strictly historical,
including statements regarding the proposed acquisition, the
expected timetable for completing the transaction, the timetable
for and ability of QLT and InSite Vision to make future filings
with the FDA, including with respect to BromSite™ and DexaSite™,
and to conduct future clinical trials, including with respect to
the QLT retinoid product candidate, the benefits and synergies of
the transaction, including for InSite Vision’s and the combined
company’s stockholders, future opportunities for the combined
businesses, including with respect to its product candidates and
any other statements regarding events or developments that we
believe or anticipate will or may occur in the future, may be
“forward-looking” statements within the meaning of the Private
Securities Litigation Reform Act of 1995, and involve a number of
risks and uncertainties. There are a number of important factors
that could cause actual events to differ materially from those
suggested or indicated by such forward-looking statements and you
should not place undue reliance on any such forward-looking
statements. These factors include risks and uncertainties related
to, among other things: general economic conditions and conditions
affecting the industries in which QLT and InSite Vision operate;
the commercial success of QLT’s and InSite Vision’s products; the
parties’ ability to satisfy the merger agreement conditions and
consummate the merger on the anticipated timeline or at all; QLT’s
ability to successfully integrate InSite Vision’s operations and
employees with QLT’s existing business; the ability to realize
anticipated growth, synergies and cost savings; QLT’s and InSite
Vision’s research and development risks, including with respect to
QLT091001, QLT’s lead retinoid product candidate, for the treatment
of inherited retinal diseases, and InSite Vision’s efforts to
develop and obtain FDA approval of BromSite™ and DexaSite™, and the
combined company’s ability to successfully commercialize, either
alone or with partners, such product candidates. Additional
information regarding the factors that may cause actual results to
differ materially from these forward-looking statements is
available in (i) QLT’s SEC filings, including its Annual Report on
Form 10-K (as amended) for the fiscal year ended December 31, 2014
and Quarterly Report on Form 10-Q for the quarterly period ended
March 31, 2015 under the caption “Risk Factors” and elsewhere in
such reports; and (ii) InSite Vision’s SEC filings, including its
Annual Report on Form 10-K for the fiscal year ended December 31,
2014 and Quarterly Report on Form 10-Q for the quarterly period
ended March 31, 2015 under the caption “Risk Factors” and elsewhere
in such reports. The forward-looking statements made herein speak
only as of the date hereof and none of QLT, InSite Vision or any of
their respective affiliates assumes any obligation to update or
revise any forward-looking statement, whether as a result of new
information, future events and developments or otherwise, except as
required by law.
Important Information for Investors and Stockholders
This communication does not constitute an offer to sell or the
solicitation of an offer to buy any securities or a solicitation of
any vote or approval, nor will there be any sale of securities in
any jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. In connection with the
proposed transaction between QLT and InSite Vision, QLT will file
with the Securities and Exchange Commission (the “SEC”) a
registration statement on Form S-4 that will include a proxy
statement of InSite Vision that also constitutes a prospectus of
QLT. The definitive proxy statement/prospectus will be delivered to
stockholders of InSite Vision. INVESTORS AND SECURITY HOLDERS OF
INSITE VISION ARE URGED TO READ THE DEFINITIVE PROXY
STATEMENT/PROSPECTUS AND OTHER DOCUMENTS THAT WILL BE FILED WITH
THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE
BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Investors in
InSite Vision will be able to obtain free copies of the
registration statement and the definitive proxy
statement/prospectus (when available) and other documents filed
with the SEC by QLT and InSite Vision through the website
maintained by the SEC at http://www.sec.gov. Copies of the
documents filed with the SEC by QLT will be available free of
charge on QLT’s website at www.QLT.com or by contacting QLT’s
Investor and Media Relations at 212-600-1902. Copies of the
documents filed with the SEC by InSite Vision will be available
free of charge on InSite Vision’s website at www.InSiteVision.com
or by contacting InSite Vision at the numbers provided for Media
and Investor Inquiries below.
Participants in the Merger Solicitation
QLT, InSite Vision, their respective directors and certain of
their executive officers and employees may be considered
participants in the solicitation of proxies in connection with the
proposed transaction. Information regarding the persons who may,
under the rules of the SEC, be deemed participants in the
solicitation of the QLT and InSite Vision shareholders in
connection with the proposed merger and a description of their
direct and indirect interests, by security holdings or otherwise,
will be set forth in the proxy statement/prospectus when it is
filed with the SEC. Information about the directors and executive
officers of QLT is set forth in its Annual Report on Form 10-K/A,
which was filed with the SEC on April 30, 2015. Information about
the directors and executive officers of InSite Vision is set forth
in its proxy statement for its 2015 annual meeting of shareholders,
which was filed with the SEC on February 19, 2015.
AzaSite®, DuraSite® and DuraSite® 2 are registered
trademarks of InSite Vision Incorporated.
AzaSite Xtra™, AzaSite Plus™, BromSite™, DexaSite™ and
BromDex™ are trademarks of InSite Vision
Incorporated.
Besivance® is a registered trademark of Bausch + Lomb
Incorporated.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20150608006051/en/
InSite VisionLouis Drapeau, 510-747-1220Chief Financial
Officermail@insite.comorMedia and Investor InquiriesBCC
PartnersKaren L. Bergman, 650-575-1509kbergman@bccpartners.comSusan
Pietropaolo, 845-638-6290spietropaolo@bccpartners.com
Novelion Therapeutics (NASDAQ:NVLN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Novelion Therapeutics (NASDAQ:NVLN)
Historical Stock Chart
From Apr 2023 to Apr 2024